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FDA 510(k) Application Details - K182341
Device Classification Name
Catheter, Peripheral, Atherectomy
More FDA Info for this Device
510(K) Number
K182341
Device Name
Catheter, Peripheral, Atherectomy
Applicant
Avinger, Inc.
400 Chesapeake Drive
Redwood City, CA 94063 US
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Contact
Thomas Lawson
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Regulation Number
870.4875
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Classification Product Code
MCW
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More FDA Info for this Product Code
Date Received
08/28/2018
Decision Date
04/09/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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